The system consists of a disposable handpiece attached to a console. The capsulotomy tip has a 6 mm diameter silicone suction cup containing a 5 mm Nitinol capsulotomy ring. Console push button operation automatically enables insertion through a 2.4 mm corneal incision. Suction apposes the cutting ring to the anterior capsule. After the series of micro pulse cuts are delivered, the suction is released and the device removed from the eye. Cutting is due to rapid phase transition of trapped water molecules between the cutting ring and the capsule resulting in instantaneous mechanical capsule cleavage.

Results:

NanoPulse Capsule Surgery (NPCS) using the disposable capsulotomy device was performed on rabbit and human cadaver eyes. Device use required approximately 15-20 seconds from insertion to removal from the anterior chamber. Each time, precise, perfectly circular capsulotomies without tags were reproducibly completed in a few milliseconds. Miyake-Apple imaging showed minimal zonular movement during NPCS. Scanning electron microscopy showed a smooth capsule edge that resembled a manual capsulorhrexis. Results of quantitative stretch testing to compare NPCS with manual capsulorhexis and femtosecond laser capsulotomy will be presented, along with results of First in Man testing in patients under an FDA IDE.

Conclusions:

A novel disposable automated device is able to create precisely sized and circular capsulotomies in a few milliseconds. The smooth and continuous capsular edge resembles that of a manual capsulorhexis, rather than a femtosecond laser capsulotomy edge. It appears to be very strong and resistant to tearing. Results of human clinical testing will be presented. This technology may prove able to automate and shorten the procedural time for the capsulotomy step at an affordable cost, and without disrupting patient flow in the operating room.

Financial Interest:

One of the authors gains financially from product or procedure presented, One of the authors has significant investment interest in a company producing, developing or supplying product or procedure presented